Stent designs to cover catheter access site

ABSTRACT

Methods, apparatuses and systems are described for delivering a stent through an access hole of a body lumen and covering up the access hole after deploying the stent. Stents are described that include a stent body defining a body lumen contact surface area and a deployable member configured to deploy from the stent body and increase the body lumen contact surface area of the stent. Deployable members that hinge, unroll, extend, expand, and coaxially translate with respect to the stent body are described. A system for delivering a stent into a body lumen are described that may include a coverage member configured to at least partially cover the hole in the wall of the stent upon withdrawing a tubular member through the hole in the wall of the stent. Coverage members may include a self-sealing membrane, a flap valve, or a hinged valve.

CROSS REFERENCE

The present application is a Divisional of U.S. patent application Ser.No. 16/242,587, filed Jan. 8, 2019, entitled “STENT DESIGNS TO COVERCATHETER ACCESS SITE”, which is incorporated by its entirety herein.

BACKGROUND

Diseases and disorders of the gallbladder, pancreas, and bile ducts(i.e., pancreaticobiliary system) are associated with significantmorbidity, mortality, and impaired quality of life. Obstructions,tumors, injuries, leakages, inflammation, infection and lesions canoccur in these structures, which can eventually lead to conditions suchas biliary colic, cholecystitis, choledocholithiasis, cholelithiasis,pancreatitis, pancreatic duct stone formations, and chronic abdominalpain. Diseases of the pancreaticobiliary system may also be associatedwith nutritional disorders, such as malnutrition, obesity, and highcholesterol.

To treat a biliary obstruction, a standard endoscopic retrogradecholangiopancreatography (ERCP) procedure may be performed. In general,a standard ERCP procedure includes placing an endoscope down theesophagus, through the stomach, and into the duodenum. A guide wire isthen deployed from the endoscope, through the major duodenal papilla,and into the common bile duct along the retrograde direction. Once theguide wire is in place, a stent or other treatment device may beadvanced over the guide wire into the common bile duct to removeobstructions, biopsy tumors, or otherwise treat the biliary system.

In some instances, the bile duct is inaccessible from the duodenum usingthe standard retrograde approach, such as when the biliary obstructionis too large or otherwise difficult to pass through with a guide wire.The risk of causing pancreatitis by repeatedly prodding the majorduodenal papilla with the guide wire is another reason the standardretrograde approach may be avoided. In other cases, duodenal access tothe bile duct may be blocked or impeded. In these circumstances, anantegrade approach to treating the biliary obstruction may be used.

A particular antegrade approach, known as a “Rendezvous” procedure,involves using an EUS (Endoscopic Ultrasonography) endoscope to accessthe common bile duct above (i.e., retrograde to) the blockage and thendirecting a guide wire through the access site into the common bileduct, across the blockage along the antegrade direction, and through thepapilla into the duodenum. The EUS endoscope is then withdrawn from thepatient, leaving the guide wire in place, and is exchanged for astandard ERCP endoscope. Once the scope exchange is complete, theportion of the guide wire in the duodenum is grasped and pulled back upthrough the ERCP endoscope. The clinician may then deploy a stent orother treatment device over the guide wire in the retrograde directioninto the common bile duct just as in a standard ERCP procedure.

Although the “Rendezvous” approach may be preferred over the standardERCP procedure in certain instances, the “Rendezvous” approach is timeconsuming, requires a complex scope exchange, and often causes theclinician to lose guide wire placement. Therefore, there may be a needfor improved methods of treating a biliary blockage when the standardERCP procedure is infeasible.

SUMMARY

The described features generally relate to methods, devices, and systemsfor delivering a stent into a body lumen through an access hole andcovering the access hole after deploying the stent. Stent deliverysystems are described for delivering the stent through the access holeand deploying the stent within the body lumen. Stents may include adeployable member that deploys from the body of the stent to cover theaccess hole after the stent delivery system is withdrawn back throughthe access hole. The described stent delivery systems may be used todeliver a stent through the wall of the common bile duct for directantegrade placement of the stent across the major duodenal papilla. Adeployable member may deploy from the body of the stent to cover theaccess hole in the common bile duct after the stent delivery system iswithdrawn to prevent bile from leaking into the surrounding tissue.

The deployable member is generally configured to deploy during or afterthe withdrawal of the stent delivery system through the access hole. Insome examples, deploying the deployable member includes releasing thedeployable member from a constrained configuration. Additionally oralternatively, deploying the deployable member may include pulling onthe deployable member.

Various stent designs are provided for covering an access hole. Ingeneral, a stent includes a stent body that defines a body lumen contactsurface area when deployed within the body lumen. A stent also includesa deployable member configured to deploy from the stent body to increasethe body lumen contact surface area of the stent.

The deployable member may deploy from the stent body in a variety ofways. For example, the deployable member may hinge from inside the stentbody to outside the stent body. The deployable member may unroll frominside the stent body to outside the stent body. In other examples, thedeployable member is configured to extend in length axially in adirection away from the stent body. In yet other examples, thedeployable member is configured to translate axially in a direction awayfrom the stent body from inside the stent body to outside the stentbody.

The deployable member may include at least one flap hingedly coupledwith the stent body. Alternatively, the deployable member may include aplurality of flaps hingedly coupled with the stent body andequidistantly spaced around a circumference of the stent body. In otherexamples, the deployable member is an accordion tube coupled with an endof the stent body. The accordion tube may include one or more integratedspring elements. In some examples, the deployable member is a tubularbody sized to fit inside the stent body of the stent. In yet otherexamples, the deployable member is a flexible sleeve.

Systems for delivering a stent into a body lumen are also described. Incertain aspects, a system includes a stent, a stent delivery systemconfigured to deliver the stent through an access site in a wall of thebody lumen, a tubular member configured to retract the stent toward theaccess site such that a proximal portion of the stent at least partiallycovers the access site, wherein the stent is disposed onto the tubularmember such that the tubular member extends inside the stent along adistal portion of the stent, extends through a hole in a wall of thestent, and extends outside of the stent along the proximal portion ofthe stent, and a coverage member configured to at least partially coverthe hole in the wall of the stent upon withdrawing the tubular memberthrough the hole in the wall of the stent.

In certain aspects, the coverage member may comprise a self-sealingmembrane material disposed on an outer surface of the wall of the stentand configured to seal the hole in the wall of the stent uponwithdrawing the tubular member through the hole in the wall of thestent. In some examples, the coverage member may comprise a flap valveconfigured to seal the hole in the wall of the stent upon withdrawingthe tubular member through the hole in the wall of the stent. In certainaspects, the coverage member may comprise a hinged valve configured tohinge such that upon withdrawing the tubular member through the hole inthe wall of the stent, the hinged valve hinges to at least partiallycover the hole in the wall of the stent. The system may also include apolymer jacket disposed on an outer surface of a central portion of thestent, wherein the coverage member is coupled with the polymer jacket.

Certain embodiments of the present disclosure may include some, all, ornone of the above advantages or features. One or more other technicaladvantages or features may be readily apparent to those skilled in theart from the figures, descriptions, and claims included herein.Moreover, while specific advantages or features have been enumeratedabove, various embodiments may include all, some, or none of theenumerated advantages or features.

Further scope of the applicability of the described methods andapparatuses will become apparent from the following detaileddescription, claims, and drawings. The detailed description and specificexamples are given by way of illustration only, since various changesand modifications within the spirit and scope of the description willbecome apparent to those skilled in the art.

BRIEF DESCRIPTION OF THE DRAWINGS

A further understanding of the nature and advantages of the embodimentsmay be realized by reference to the following drawings. In the appendedfigures, similar components or features may have the same referencelabel. Further, various components of the same type may be distinguishedby following the reference label by a dash and a second label thatdistinguishes among the similar components. If only the first referencelabel is used in the specification, the description is applicable to anyone of the similar components having the same first reference labelirrespective of the second reference label.

FIG. 1A illustrates a stent delivery system in accordance with aspectsof the present disclosure;

FIG. 1B illustrates a stent delivery system within a body lumen inaccordance with aspects of the present disclosure;

FIG. 1C illustrates a stent with a deployable member within a body lumenin accordance with aspects of the present disclosure;

FIG. 2A illustrates a stent with a flap deployable member in a stowedconfiguration in accordance with aspects of the present disclosure;

FIG. 2B illustrates a stent with a flap deployable member in a deployedconfiguration in accordance with aspects of the present disclosure;

FIG. 3A illustrates a stent with a multi-flap deployable member in astowed configuration in accordance with aspects of the presentdisclosure;

FIG. 3B illustrates a stent with a multi-flap deployable member in adeployed configuration in accordance with aspects of the presentdisclosure;

FIG. 4A illustrates a stent with a tubular deployable member in a stowedconfiguration in accordance with aspects of the present disclosure;

FIG. 4B illustrates a stent with a tubular deployable member in adeployed configuration in accordance with aspects of the presentdisclosure;

FIG. 5A illustrates a stent with a tubular deployable member in a stowedconfiguration in accordance with aspects of the present disclosure;

FIG. 5B illustrates a stent with a tubular deployable member in adeployed configuration in accordance with aspects of the presentdisclosure;

FIG. 6A illustrates a stent with a sleeve deployable member in a stowedconfiguration in accordance with aspects of the present disclosure;

FIG. 6B illustrates a stent with a sleeve deployable member in apartially deployed configuration in accordance with aspects of thepresent disclosure;

FIG. 6C illustrates a stent with a sleeve deployable member in a fullydeployed configuration in accordance with aspects of the presentdisclosure;

FIG. 7A illustrates a stent with a tubular deployable member in a stowedconfiguration in accordance with aspects of the present disclosure;

FIG. 7B illustrates a stent with a tubular deployable member in adeployed configuration in accordance with aspects of the presentdisclosure;

FIG. 8 illustrates a stent with a tubular deployable member in adeployed configuration in accordance with aspects of the presentdisclosure;

FIG. 9 illustrates a stent with a variable radial compression profile inaccordance with aspects of the present disclosure;

FIG. 10 illustrates a stent delivery system for delivering a stent to abody lumen of the pancreaticobiliary system in accordance with aspectsof the present disclosure;

FIG. 11 illustrates a stent delivery system for delivering a stent to abody lumen of the pancreaticobiliary system in accordance with aspectsof the present disclosure;

FIG. 12A illustrates a stent delivery system with the stent retractedtowards the access site in accordance with aspects of the presentdisclosure;

FIG. 12B illustrates a stent delivery system with the stent fullydeployed in accordance with aspects of the present disclosure;

FIG. 13 illustrates a stent delivery system with a stent with a flapvalve in accordance with aspects of the present disclosure;

FIG. 14 illustrates a stent delivery system with a stent with a hingedvalve in accordance with aspects of the present disclosure;

FIG. 15 illustrates a stent delivery system with a stent with aself-sealing membrane in accordance with aspects of the presentdisclosure;

FIGS. 16-18 illustrate flowcharts of a method for delivering a stentwithin a body lumen in accordance with aspects of the presentdisclosure.

DETAILED DESCRIPTION

The present disclosure is generally directed to placing a stent within abody lumen. In certain procedures described herein, to place a stentwithin a body lumen, the luminal wall is pierced and a stent deliverysystem is advanced through the hole (i.e., access hole) and positionedat the target site (e.g., across an obstruction). The stent is thendeployed from the stent delivery system, and the stent delivery systemis withdrawn back out of the lumen through the same hole. If the hole isnot covered, fluid from the lumen may leak out into the surroundingtissue and organs, which may potentially cause serious discomfort orother medical complications.

Apparatuses, systems, and methods are described herein for covering theaccess hole after the stent delivery system is withdrawn from the bodylumen. For example, stents are described that include one or moredeployable members that deploy after the stent delivery system iswithdrawn to cover the access hole. The deployable member may beinitially stowed within the stent and configured to deploy from insidethe stent once the stent delivery system is withdrawn. The stentdelivery system may interact with the deployable member to deploy it byreleasing it from a constrained configuration or pulling on it as it iswithdrawn from the access hole.

In some cases, apparatuses, systems, and methods are described hereinfor covering a hole in a wall of the stent after the stent deliverysystem (e.g., the guidewire lumen and guidewire) are withdrawn from thebody lumen. In such cases, the stent may include a coverage memberconfigured to seal the hole in the wall of the stent. The coveragemember may be an example of a flap valve, a hinged vale, or aself-sealing membrane.

Embodiments of the present disclosure are now described in detail withreference to the drawings. As used herein, the term “clinician” refersto a doctor, surgeon, nurse, or any other care provider and may includesupport personnel. The term “proximal” will refer to the portion of thedevice or component thereof that is closer to the clinician and the term‘distal” will refer to the portion of the device or component thereofthat is farther from the clinician.

FIG. 1A shows a stent delivery system 100 in accordance with aspects ofthe present disclosure. The stent delivery system 100 may be configuredto place a stent 105 within a body lumen 180 to restore luminal flowacross narrowed areas or blockages within the body lumen 180. The stentdelivery system 100 may be sized or otherwise adapted to place a stent105 within any body lumen 180, such as those associated with thepancreaticobiliary system, the arterial system, the bronchial system,the urinary system, or any other luminal system that may require stenttreatment. The stent delivery system 100 generally includes an outersheath 110 and a pusher 115. The guidewire lumen 120 may be part of thestent delivery system 100 or may be a separate component. The stentdelivery system 100 can be provided as individual components,selectively combined components, or all together as a kit of components.

The outer sheath 110 is an elongate, tubular, flexible structure that issized to provide a conduit through which the stent 105 travels to thetarget body lumen 180. The outer sheath 110 may access the human bodythrough the working channel of an endoscope, for example. As will beappreciated, the outer sheath 110 may be made from any number ofbiocompatible materials or combinations of materials suitable formedical sheaths, catheters, and the like. The pusher 115 is sized to beadvanced through the outer sheath 110 and is generally constructed froma flexible material with sufficient columnar strength to push the stent105 from the distal end 125 of the outer sheath 110 into the body lumen180. The pusher 115 may be a solid rod, or may include an internal lumenthrough which a guidewire lumen 120 may pass, as illustrated in FIG. 1A.Like the outer sheath 110, the pusher 115 may be made from any number ofsuitable materials for use in the human body.

In general, a stent 105 is a frame or scaffolding structure sized forplacement within a body lumen 180 and configured to provide structuralsupport to the inner surface of the body lumen 180. A stent 105 may beused to restore patency across narrowed or blocked areas within the bodylumen 180 due to inflammation, tumors, plaque buildup, or any otherobstructive feature. For example, as described in more detail withreference to FIGS. 10-11, a stent 105 may be placed across the majorduodenal papilla to restore luminal flow through the common bile ductinto the duodenum. Although references to the pancreaticobiliary systemare provided herein, it should be appreciated that the stents 105described herein may be used in any body lumen 180.

The stent 105 may be a self-expanding stent. In such examples, the stent105 is radially compressed within the outer sheath 110 and willnaturally expand to a larger circumference upon exiting the outer sheath110. Alternatively, the stent 105 may require a balloon or similarexpansion element to expand the stent 105 within the body lumen 180. Inany case, the stent 105 is generally sized such that it contacts a fullycircumferential inner surface of the body lumen 180 when expanded. Thecontact surface between the stent 105 and the inner surface of the bodylumen 180 is referred to herein as the body lumen contact surface area.

The stent 105 may be made from any number of materials, combinations ofmaterials, and constructions. For example, the stent 105 may be abraided stent made from a plurality of wires joined together in across-hatch configuration. The stent 105 depicted in FIGS. 1-7 and 9-11are braided stents or at least include a stent body 135 that is braided.However, it should be appreciated that the stent 105 may be made fromother stent constructions or combinations of stent constructions. Inother examples, the stent 105 is a laser-cut stent formed from a singlemetallic tube with regions cut away for increased flexibility. In yetother examples, the stent 105 is a wire-form stent formed by one or morehelically wrapped wires, as depicted in FIG. 8. It may be appreciatedthat the different stent constructions may exhibit particularcharacteristics such as radial expansive force, flexibility, reducedforeshortening, or migration resistance that may render a certainconstruction advantageous for a particular use. As described withreference to FIG. 8, a stent 105 may include some portions made from onestent construction (e.g., laser-cut) and another portion made fromanother stent construction (e.g., braided) to take advantage of theunique characteristics of each construction. In addition, as describedwith reference to FIG. 9, the radial expansion force exhibited by thestent 105 on the inner surface of the body lumen 180 may be varied alongthe length of the stent 105 to improve migration resistance and toprovide structural support where it is needed most.

The individual wires or frame of the stent 105 may be made from anynumber of metallic materials including, but not limited to, titanium,nitinol, or stainless steel. It should be appreciated that othermetallic or non-metallic materials may be used to construct the stent105 that provide suitable flexibility, stiffness, and biocompatibility.The stent 105 may include a polymeric or fabric sleeve that covers someor all of the surface of the stent 105. Such a sleeve may protect theinner surface of the body lumen 180 from the bare metal of the stent 105and may prevent tissue ingrowth. In some examples, the stent 105 is adrug-eluting stent.

Referring still to FIG. 1A, to place the stent delivery system 100within the body lumen 180, an access site 185 is formed through the wall190 of the body lumen 180, and the guidewire lumen 120 is then advancedthrough the access site 185 and into the body lumen 180. Systems,apparatuses, and methods for accessing a body lumen 180 and directing aguidewire lumen 120 into the body lumen 180 in a preferred direction aredescribed in U.S. Patent Application No. XX/XXX,XXX, titled “CatheterWith Pre-Formed Geometry for Endoscopic Ultrasound-Guided Access”commonly assigned to the assignee of the present application, the entirecontents of which are incorporated herein.

Once the guidewire lumen 120 is in place, the outer sheath 110 isadvanced distally, as indicated by arrow 140, over the guidewire lumen120, through the access site 185, and into the body lumen 180. Advancingthe outer sheath 110 through the access site 185 may dilate the accesssite 185 (as shown in FIG. 1B) beyond the initial size required toaccess the body lumen 180 with the guidewire lumen 120 (as shown in FIG.1A). In some instances, the outer diameter of the outer sheath 110 maybe as large as 10 F (3.33 mm) or larger. It may be appreciated thatdilating the access site 185 may allow fluid to leak from the body lumen180 into the surrounding tissue once the stent delivery system 100 iswithdrawn from the body lumen 180, thereby potentially causingdiscomfort or other complications to the patient.

FIG. 1B shows the stent delivery system 100 of FIG. 1A within the bodylumen 180 and with the stent 105 fully deployed. To deploy the stent 105from the stent delivery system 100, the pusher 115 is advanced distally,as indicated by arrow 140, with respect to the outer sheath 110, or theouter sheath 110 is withdrawn proximally with respect to the pusher 115.Because the pusher 115 abuts against the stent 105, the stent 105 willbe pushed from the distal end 125 of the outer sheath 110 as the pusher115 is advanced distally or as the outer sheath 110 is withdrawnproximally. In the case of a self-expanding stent, the stent 105 expandsto contact the inner surface of the body lumen 180 as it exits the outersheath 110.

FIG. 1C shows the stent 105 of FIGS. 1A-1B fully deployed within thebody lumen 180 and with the stent delivery system 100 fully withdrawnfrom the body lumen 180. To withdraw the stent delivery system 100 aftersuccessful placement of the stent 105, the outer sheath 110 and thepusher 115 are withdrawn back through the access site 185. The guidewirelumen 120 is also withdrawn back through the access site 185 and can bedone so before, after, or at the same time as the outer sheath 110 andpusher 115. After the stent delivery system 100 is withdrawn from thebody lumen 180, liquid from the lumen 180 may leak into the surroundingtissue. In the case of the common bile duct, bile leakage into thesurrounding tissue may cause serious discomfort to the patient.

To prevent or at least impede the flow of fluid from the body lumen 180,features of the stent 105 or stent delivery system 100 are configured toat least partially cover the access site 185. For example, the stent 105may include a deployable member 130 that deploys from the stent body 135of the stent 105 to cover the access site 185. In general, oncedeployed, the deployable member 130 increases the body lumen contactsurface area of the stent 105. The deployable member 130 is generallycoupled with the stent body 135 and remains attached to the stent body135 after deployment. As described with reference to various figures,the deployable member 130 may deploy from the stent body 135 by hinging,unrolling, extending, expanding, or translating away from the stent body135. The deployable member 130 may contact a partially circumferentialportion of the body lumen 180 (as shown in FIG. 1C) or may insteadcontact a fully circumferential portion.

The deployable member 130 may include one or more separate elements thatmay be made from the same materials and construction as the stent body135 or may instead be made from different materials or construction. Forexample, the deployable member 130 may include a frame or scaffoldingstructure like the stent body 135. If made from a frame or scaffoldingstructure, the deployable member 130 may include a covering or webbingthat at least partially prevents liquid from flowing through thedeployable member 130. Additionally or alternatively, the frame orscaffolding may be densely arranged (e.g., a mesh) to at least partiallyprevent the flow of liquid therethrough. In some cases, the deployablemember 130 is a solid, unitary piece without a frame. The deployablemember 130 may include materials with properties particularly suited forclosing an access site 185 such materials that promote coagulation orhealing, or materials that are absorbent or adherent.

The deployable member 130 may be triggered to deploy during or after thestent delivery system 100 is withdrawn back through the access site 185.In some examples, the deployable member 130 is constrained in apre-deployed or stowed position by some component of the stent deliverysystem 100 or the stent 105, and by removing the stent delivery system100 from the body lumen 180, the deployable member 130 is therebyunconstrained and will deploy to cover the access site 185. Additionallyor alternatively, some component of the stent delivery system 100 maypull on or otherwise urge the deployable member 130 into the deployedposition either during or after the stent delivery system 100 has beenwithdrawn from the body lumen 180.

FIG. 2A shows a fully deployed stent 105-a within a body lumen 180 inaccordance with aspects of the present disclosure. The stent 105-a maybe an example of the stent 105 of FIGS. 1A-1C. The stent 105-a includesa deployable member 130-a that is shown stowed within the stent body135-a. The deployable member 130-a is a flap that is hingedly coupledwith the stent body 135-a. The deployable member 130-a may deploy fromthe stent body 135-a by hinging, as indicated by arrow 205, from insidethe stent body 135-a (as shown in FIG. 2A) to outside the stent body135-a (as shown in FIG. 2B), thereby increasing the body lumen contactsurface area of the stent 105-a. As such, the length of the deployablemember 130-a is selected such that it clears the inner surface of thestent body 135-a as it hinges from inside to outside the stent body135-a.

The deployable member 130-a may be configured to spring open to thedeployed configuration shown in FIG. 2B when unconstrained. For example,the deployable member 130-a may be made from or include a material orcomponent that stores elastic potential energy when in the stowedconfiguration. In such examples, some component of the stent deliverysystem 100 (e.g., the guidewire lumen 120 or the pusher 115) may holdthe deployable member 130-a down in the stowed configuration while thestent delivery system 100 is still within the body lumen 180. As such,once the particular component is withdrawn from the body lumen 180, thedeployable member 130-a is free to spring open to the deployedconfiguration shown in FIG. 2B.

Additionally or alternatively, the deployable member 130-a may bedetachably connected with some component of the stent delivery system100 by a pull string (e.g., a surgical suture). In such examples, as thestent delivery system 100 is withdrawn from the body lumen 180, thedeployable member 130-a is pulled into the deployed configuration shownin FIG. 2B by the stent delivery system 100 as it exits the access site185. Once the stent delivery system 100 is fully withdrawn from the bodylumen 180, the connection between the stent delivery system 100 and thedeployable member 130-a may be detached (e.g., breaking or otherwisedisconnecting the pull string).

The deployable member 130-a may include a frame or other supportstructure and may be made from the same material or materials as thestent body 135-a. In other examples, the deployable member 130-a is madefrom a different material than the stent body 135-a. The materialsforming the structure of the deployable member 130-a may be denselyarranged (e.g., mesh-like) so as to impede the flow of fluid through thedeployable member 130-a. The deployable member 130-a may also include aweb, coating, or some other covering (e.g., silicon, polyurethane,polytetrafluoroetheylene, fabric) that prevents or at least impedes theflow of fluid therethrough.

FIG. 3A shows a fully deployed stent 105-b within a body lumen 180 inaccordance with aspects of the present disclosure. The stent 105-b maybe an example of the stent 105 described with reference to FIGS. 1A-1C.The stent 105-b includes a deployable member 130-b that is shown stowedwithin the stent body 135-b. The deployable member 130-b includes aplurality of flaps that are hingedly coupled with the stent body 135-b.The individual flaps of the deployable member 130-b may be an example ofor include features of the single flap of the deployable member 130-adescribed with reference to FIGS. 2A-2B. The individual flaps of thedeployable member 130-b may deploy from the stent body 135-b by hinging,as indicated by arrow 305, from inside the stent body 135-b (as shown inFIG. 3A) to outside the stent body 135-b (as shown in FIG. 3B), therebyincreasing the body lumen contact surface area of the stent 105-b.

The individual flaps of the deployable member 130-b may be equidistantlyspaced around the circumference of the stent body 135-b. As such, oncedeployed, the deployable member 130-b provides coverage around a fullcircumference of the body lumen 180. Alternatively, the flaps may bespaced only around a partial circumference of the stent body 135-b. Insuch cases, the stent 105-b is radially aligned with respect to the bodylumen 180 such that the deployable member 130-b covers the access site185 when deployed. Depending on the number and size of the flaps of thedeployable member 130-b, the flaps may at least partially overlap andtherefore may deploy in serial fashion around the circumference of thestent body 135-b.

The deployable member 130-b may be configured to spring open to thedeployed configuration shown in FIG. 3B when unconstrained. For example,the deployable member 130-b may be made from or include a material orcomponent that stores elastic potential energy when in the stowedconfiguration. In such examples, some component of the stent deliverysystem 100 (e.g., the guidewire lumen 120 or the pusher 115) may holdthe deployable member 130-b down in the stowed configuration while thestent delivery system 100 is still within the body lumen 180. As such,once the particular component is withdrawn from the body lumen 180, thedeployable member 130-b is free to spring open to the deployedconfiguration shown in FIG. 3B.

Additionally or alternatively, the deployable member 130-b may bedetachably connected with some component of the stent delivery system100 by a pull string (e.g., a surgical suture). In such examples, as thestent delivery system 100 is withdrawn from the body lumen 180, thedeployable member 130-b is pulled into the deployed configuration shownin FIG. 3B by the stent delivery system 100 as it exits the access site185. Once the stent delivery system 100 is fully withdrawn from the bodylumen 180, the connection between the stent delivery system 100 and thedeployable member 130-b may be detached (e.g., breaking or otherwisedisconnecting the pull string).

The individual flaps of the deployable member 130-b may include a frameor other support structure and may be made from the same material ormaterials as the stent body 135-b. In other examples, the deployablemember 130-b is made from a different material than the stent body135-b. The materials forming the structure of the deployable member130-b may be densely arranged (e.g., mesh-like) so as to impede the flowof fluid through the deployable member 130-b. The deployable member130-b may also include a web, coating, or some other covering (e.g.,silicon, polyurethane, polytetrafluoroetheylene, fabric) that preventsor at least impedes the flow of fluid therethrough.

FIG. 4A shows a fully deployed stent 105-c within a body lumen 180 inaccordance with aspects of the present disclosure. The stent 105-c maybe an example of the stent 105 described with reference to FIGS. 1A-1C.The stent 105-c includes a deployable member 130-c that is shown in astowed configuration. The deployable member 130-c is a tube configuredto expand and collapse like an accordion, and is coupled with the end ofthe stent body 135-c proximate the access site 185. In the stowedconfiguration, the deployable member 130-c is collapsed down as shown inFIG. 4A and may be partially or fully housed within the stent body135-c. The deployable member 130-c may deploy from the stent body 135-cby extending in length axially away from the stent body 135-c (as shownby arrow 405) until it is elongated (as shown in FIG. 4B), therebyincreasing the body lumen contact surface area of the stent 105-c.

The deployable member 130-c may be configured to spring open to thedeployed configuration shown in FIG. 4B when unconstrained. For example,the deployable member 130-c may be made from or include a material orcomponent that stores elastic potential energy when in the stowedconfiguration. In such examples, some component of the stent deliverysystem 100 (e.g., the guidewire lumen 120 or the pusher 115) may holdthe deployable member 130-c in the stowed configuration while the stentdelivery system 100 is still within the body lumen 180. As such, oncethe particular component is withdrawn from the body lumen 180, thedeployable member 130-c is free to spring open to the deployedconfiguration shown in FIG. 4B.

Additionally or alternatively, the deployable member 130-c may bedetachably connected with some component of the stent delivery system100 by a pull string (e.g., a surgical suture). In such examples, as thestent delivery system 100 is withdrawn from the body lumen 180, thedeployable member 130-c is pulled into the deployed configuration shownin FIG. 4B by the stent delivery system 100 as it exits the access site185. Once the stent delivery system 100 is fully withdrawn from the bodylumen 180, the connection between the stent delivery system 100 and thedeployable member 130-c may be detached (e.g., breaking or otherwisedisconnecting the pull string).

The deployable member 130-c may include a frame or other supportstructure and may be made from the same material or materials as thestent body 135-c. In other examples, the deployable member 130-c is madefrom a different material than the stent body 135-c. The materialsforming the structure of the deployable member 130-c may be denselyarranged (e.g., mesh-like) so as to impede the flow of fluid through thedeployable member 130-c. The deployable member 130-c may also include aweb, coating, or some other covering (e.g., silicon, polyurethane,polytetrafluoroetheylene, fabric) that prevents or at least impedes theflow of fluid therethrough.

FIG. 5A shows a fully deployed stent 105-d within a body lumen 180 inaccordance with aspects of the present disclosure. The stent 105-d maybe an example of the stent 105 described with reference to FIGS. 1A-1C.The stent 105-d includes a deployable member 130-d that is shown in astowed configuration. The deployable member 130-d is a tube configuredto expand and collapse like an accordion, and is coupled with the end ofthe stent body 135-d proximate the access site 185. In the stowedconfiguration, the deployable member 130-d is collapsed down as shown inFIG. 5A and may be partially or fully housed within the stent body135-d. The deployable member 130-d may deploy from the stent body 135-dby extending in length axially away from the stent body 135-d, asindicated by arrow 505, until it is elongated (as shown in FIG. 5B),thereby increasing the body lumen contact surface area of the stent105-d.

The deployable member 130-d may be configured to spring open to thedeployed configuration shown in FIG. 5B when unconstrained. For example,the deployable member 130-d may be made from a material that storeselastic potential energy when in the stowed configuration. Addition oralternatively, the deployable member 130-d may include one or moreintegrated spring elements 510 that urge the deployable member 130-d toelongate axially. In such examples, some component of the stent deliverysystem 100 (e.g., the guidewire lumen 120 or the pusher 115) may holdthe deployable member 130-d in the stowed configuration while the stentdelivery system 100 is still within the body lumen 180. As such, oncethe particular component is withdrawn from the body lumen 180, thedeployable member 130-d is free to spring open to the deployedconfiguration shown in FIG. 5B.

Additionally or alternatively, the deployable member 130-d may bedetachably connected with some component of the stent delivery system100 by a pull string (e.g., a surgical suture). In such examples, as thestent delivery system 100 is withdrawn from the body lumen 180, thedeployable member 130-d is pulled into the deployed configuration shownin FIG. 5B by the stent delivery system 100 as it exits the access site185. Once the stent delivery system 100 is fully withdrawn from the bodylumen 180, the connection between the stent delivery system 100 and thedeployable member 130-d may be detached (e.g., breaking or otherwisedisconnecting the pull string).

The deployable member 130-d may include a frame or other supportstructure and may be made from the same material or materials as thestent body 135-d. In other examples, the deployable member 130-d is madefrom a different material than the stent body 135-d. The materialsforming the structure of the deployable member 130-d may be denselyarranged (e.g., mesh-like) so as to impede the flow of fluid through thedeployable member 130-d. The deployable member 130-d may also include aweb, coating, or some other covering (e.g., silicon, polyurethane,polytetrafluoroetheylene, fabric) that prevents or at least impedes theflow of fluid therethrough. Alternatively, the deployable member 130-dmay be made from a relatively flimsy material that is held in agenerally cylindrical shape by the integrated spring elements 510.

FIG. 6A shows a fully deployed stent 105-e within a body lumen 180 inaccordance with aspects of the present disclosure. The stent 105-e maybe an example of the stent 105 described with reference to FIGS. 1A-1C.The stent 105-e includes a deployable member 130-e that is shown stowedwithin the stent body 135-e. The deployable member 130-e is a flexiblesleeve. In the stowed configuration, the deployable member 130-e isfolded inside the stent body 135-e as shown in FIG. 6A. The deployablemember 130-e may deploy from the stent body 135-e, as indicated by arrow605, by unrolling from inside the stent body 135-e (as shown in FIG. 6B)until it is fully unrolled (as shown in FIG. 6C), thereby increasing thebody lumen contact surface area of the stent 105-e.

The deployable member 130-e is detachably connected with a pull string610 or some other pull mechanism which is coupled with the stentdelivery system 100. As the stent delivery system 100 is withdrawn fromthe body lumen 180, the deployable member 130-e is pulled by the pullstring 610 until it unrolls from inside the stent body 135-e to outsidethe stent body 135-e, as shown in the progressions from FIG. 6A to FIG.6C. Once the stent delivery system 100 is fully withdrawn from the bodylumen 180, the pull string 610 may be detached from the deployablemember 130-e or from the stent delivery system 100.

The deployable member 130-e may include a frame or other supportstructure and may be made from the same material or materials as thestent body 135-e. In other examples, the deployable member 130-e is madefrom a different material than the stent body 135-e. The materialsforming the structure of the deployable member 130-e may be denselyarranged (e.g., mesh-like) so as to impede the flow of fluid through thedeployable member 130-e. The deployable member 130-e may also include aweb, coating, or some other covering (e.g., silicon, polyurethane,polytetrafluoroetheylene, fabric) that prevents or at least impedes theflow of fluid therethrough.

FIG. 7A shows a fully deployed stent 105-f within a body lumen 180 inaccordance with aspects of the present disclosure. The stent 105-f maybe an example of the stent 105 described with reference to FIGS. 1A-1C.The stent 105-f includes a deployable member 130-f that is shown stowedwithin the stent body 135-f. The deployable member 130-f is a tubularmember sized to fit inside the stent body 135-f. In some examples, thedeployable member 130-f is similar in structure and materials as thestent body 135-f, except with a smaller diameter. In the stowedconfiguration, the deployable member 130-f is housed inside the stentbody 135-f as shown in FIG. 7A. The distal end of the deployable member130-f is attached to the proximal end of the stent body 135-f by aflexible cuff or sleeve. The deployable member 130-e may deploy from thestent body 135-f, as indicated by arrow 705, by translating coaxiallywith the stent body 135-f from inside the stent body 135-f (as shown inFIG. 6A) to outside the stent body 135-f (as shown in FIG. 7B), therebyincreasing the body lumen contact surface area of the stent 105-f.

The deployable member 130-f is detachably connected with a pull string610 which is coupled with the stent delivery system 100. As the stentdelivery system 100 is withdrawn from the body lumen 180, the deployablemember 130-f is pulled by the pull string 610 until it exits from insidethe stent body 135-f to outside the stent body 135-f. Once the stentdelivery system 100 is fully withdrawn from the body lumen 180, the pullstring 610 may be detached from the deployable member 130-f or from thestent delivery system 100.

The deployable member 130-f may include a frame or other supportstructure and may be made from the same material or materials as thestent body 135-f. In other examples, the deployable member 130-f is madefrom a different material than the stent body 135-f. The materialsforming the structure of the deployable member 130-f may be denselyarranged (e.g., mesh-like) so as to impede the flow of fluid through thedeployable member 130-f. The deployable member 130-f may also include aweb, coating, or some other covering (e.g., silicon, polyurethane,polytetrafluoroetheylene, fabric) that prevents or at least impedes theflow of fluid therethrough.

FIG. 8 shows a fully deployed stent 105-g within a body lumen 180 inaccordance with aspects of the present disclosure. The stent 105-g maybe an example of the stent 105 described with reference to FIGS. 1A-1C.Unlike the stent bodies depicted in the previous figures, the stent body135-g is made from a helically wrapped wire-form construction. Althoughnot depicted, the stent body 135-g may instead be made from a laser-cutconstruction. In any case, the deployable member 130-g is made from adifferent construction, such as a braided stent construction. Thewire-form or laser-cut stent body 135-g experiences less foreshorteningwhen deployed from the stent delivery system 100 than a braided stent.As such, the stent body 135-g may be more accurately placed within thebody lumen 180 across the target site (e.g., across the major duodenalpapilla). The deployable member 130-g may be an example of or includefeatures of any of the deployable members 135-c, 135-d, 135-e, or 135-fdescribed with reference to FIGS. 4-7.

FIG. 9 shows a fully deployed stent 105-h within a body lumen 180 inaccordance with aspects of the present disclosure. The stent 105-hincludes a stent body 135-h and a deployable member 130-h. The stent105-h and the deployable member 130-h may be an example of or includefeatures of any of the stents 105 or deployable members 130 describedwith reference to FIGS. 1-8. The stent 105-h may be configured to createa variable radial force profile across the length of the stent body135-h. For example, the radial compression exerted by the stent 105-h onthe inner surface of the body lumen 180 may be greater at the distal endof the stent 105-h (with respect to the access site 185) than at theproximal end. In some cases, the radial force is greater along a distalsection 905 of the stent body 135-h than along a proximal section 910. Avariable radial compression profile may improve stent migrationresistance, long term stent patency, and reduce tumor in-growth.

In some examples, the radial force profile is created by forming thedistal portion 905 of the stent body 135-h with braided wires that arethicker than those along the proximal portion 910 (as illustrated by thedarker lines in distal section 905). As such, the thicker wires will bestiffer and therefore capable of exerting a greater expansion force. Forexample, the wires in the proximal portion 910 may have a diameter inthe range of 0.006 inches to 0.008 inches while the wires along thedistal portion 905 may have a diameter in the range of 0.0075 inches to0.010 inches. Instead of using thicker wires, the distal section 905 maybe made from a different material that is stiffer than the material usedfor the proximal section 910. In other embodiments, the variable radialforce is accomplished by forming the distal portion 905 with a wire-formor laser-cut construction, whereas the proximal portion 910 of the stentbody 135-h is formed of a braided construction. Although two sections905,910 of varying radial expansion force are illustrated, it may beappreciated that more sections may be included to create a more linearlyincreasing force profile.

Embodiments of the present disclosure are now described in the contextof a particular stenting procedure referred to as an EndoscopicUltrasound Guided Biliary Drainage (EUS-BD) procedure. With reference toFIG. 10, a stent delivery system 1000 for placing a stent 105-i within abody lumen within the pancreaticobiliary system is illustrated inaccordance with aspects of the present disclosure. The stent deliverysystem 1000 may be an example of the stent delivery system 100 describedwith reference to FIGS. 1A-1C, and the stent 105-i may be an example ofor include features of any stent 105 described with reference to FIGS.1-9. The illustrated portions of the pancreaticobiliary system includethe common bile duct 1005, which drains bile from the gallbladder 1030into the duodenum 1015, where the bile mixes and reacts with digestingfood. As shown, the common bile duct 1005 joins with the pancreatic duct1020 at the major duodenal papilla 1010 (shown obstructed) beforedraining into the duodenum 1015.

The drainage procedure generally includes a clinician advancing anendoscope 1025 (e.g., an EUS endoscope) into the lumen of a patient'sduodenum 1015 to a position in which the bile ducts may be visualized(e.g., via endosonography). As described with reference to FIG. 1A, theclinician may then access the common bile duct 1005 by advancing aneedle or a cannula (not shown) from a working channel of the endoscope1025, through the wall of the duodenum 1015 (i.e., trans-duodenally),and then through the wall of the common bile duct 1005, thereby creatingan access site 185. The clinician may then advance a guidewire lumen120-a through the access site 185, and then advance an outer sheath110-a of the stent delivery system 1000 over the guidewire lumen 120-aand into the common bile duct 1005, thereby dilating the access site185, as described with reference to FIG. 1B.

With reference to FIG. 11, once the stent delivery system 1000 is inplace, the stent 105-i may deployed from the stent delivery system 1000across the major duodenal papilla 1010 to restore normal flow throughthe common bile duct 1005. As described with reference to FIG. 1C, oncethe stent delivery system 1000 is withdrawn from the common bile duct1005, the deployable member 130-i may deploy from the body of stent105-i to cover the access site 185. The deployable member 130-i may bean example of or include features of any deployable member 130 describedwith reference to FIGS. 1-9.

FIG. 12A illustrates a stent delivery system 1200-a with the stent 105-kretracted towards the access site 185 in accordance with aspects of thepresent disclosure. Once the outer sheath 110 is removed through theaccess site 185, the stent 105-k may be pulled towards the access site185 in a proximal direction, as indicated by arrow 1205. For example,the stent 105-k may be pulled toward the access site 185 until theproximal portion 1210 of the stent 105-k at least partially covers theaccess site 185. The stent 105-k may be retracted towards the accesssite 185 by pulling the guidewire lumen 120 in a proximal direction. Forexample, the stent 105-k may be pulled towards the access site 185 bypulling the hub 1215 of the guidewire lumen 120 in a proximal direction.In some cases, the stent 105-k may be pulled towards the access site 185by pulling the hub 1215 of the guidewire lumen 120, the lumen member(not shown), and the outer sheath hub 1220 of the outer sheath 110.

Furthermore, the stent 105-k may be repositioned within the body lumen180 to at least partially cover the access site 185. To deploy the stent105-k within the body lumen 180, a primary constrainment member 1230 maybe released. The stent 105-k may be deployed by pulling the primaryconstrainment member 1230 in a proximal direction, pulling one or moretethers coupled with the primary constrainment member 1230, or both. Insome cases, the stent 105-k may be disposed onto the guidewire lumen 120such that the guidewire lumen 120 is inside the stent 105-k along adistal portion of the stent 105-k and outside of the stent 105-k alongthe proximal portion 1210 of the stent 105-k. This configuration may bereferred to a partial side-saddle configuration.

FIG. 12B illustrates a stent delivery system 1200-b with the stent 105-kfully deployed in accordance with aspects of the present disclosure. Inthe case of a self-expanding stent, the stent 105-k expands to contactthe inner surface of the body lumen 180. Once the stent 105-k expandswithin the body lumen 180, the guidewire lumen 120 and the guidewire1225 are withdrawn through the access site 185. In some cases, theguidewire lumen 120 and the guidewire 1225 may extend through a hole ina wall of the stent 105-k. In such cases, the guidewire lumen 120 andthe guidewire 1225 may be withdrawn through the hole in the wall of thestent 105-k.

In some cases, the hole in the wall of the stent may allow for fluidfrom the body lumen 180 to leak out into the surrounding tissue andorgans. For example, because the stent 105-k may be in the partialside-saddle configuration, the hole in the stent 105-k may align withthe access site 185. In such cases, and as described below in furtherdetail, the system 1200-b may include a coverage member. The coveragemember may be configured to at least partially cover the hole in thewall of the stent 105-k upon withdrawing the guidewire lumen 120 throughthe hole in the wall of the stent 105-k, thereby at least partiallysealing the access site 185 and preventing the leakage of fluid from thebody lumen 180.

FIG. 13 illustrates a stent delivery system 1300 with a stent 105-l witha flap valve in accordance with aspects of the present disclosure. Oncethe guidewire lumen 120 and the guidewire are withdrawn through the holein the wall of the stent 105-l, the coverage member 1305 may at leastpartially cover the hole in the wall of the stent 105-l. For example,the coverage member 1305 may be an example of a flap valve. The flapvalve may be configured to seal the hole in the wall of the stent 105-lwhen the guidewire lumen 120 is withdrawn through the hole in the wallof the stent 105-l. For example, the flap valve may be a one-way controlvalve. The flap valve may be positioned on an inner diameter of thestent 105-l. In some cases, the flap valve may include one or more flapsspaced around a circumference of the hole in the wall of the stent 105-lsuch that the one or more flaps may align to form a closed flap valve.

FIG. 14 illustrates a stent delivery system 1400 with a stent 105-m witha hinged valve in accordance with aspects of the present disclosure.Once the guidewire lumen 120 and the guidewire are withdrawn through thehole in the wall of the stent 105-m, the coverage member 1405 may atleast partially cover the hole in the wall of the stent 105-m. Forexample, the coverage member 1405 may be an example of a hinged valve.The hinged valve may be configured to hinge such that when the guidewirelumen 120 is withdrawn through the hole in the wall of the stent 105-m,the hole in the wall of the stent 105-m may be covered.

In some examples, the hinged valve may rotate on an axis to remain openwhen the guidewire lumen 120 is positioned through the hole in the wallof the stent 105-m and closed when the guidewire lumen 120 is withdrawnthrough the hole in the wall of the stent 105-m. In some cases, thehinged valve may be spring-loaded such that the hinged valve recoilswhen the guidewire lumen 120 is withdrawn through the hole. For example,the hinged valve may be made from or include a material or componentthat stores elastic potential energy when the guidewire lumen 120 ispositioned through the hole in the wall of the stent 105-m. In somecases, the stent delivery system 1400 may include a polymer jacket 1410disposed on the outer surface of a central portion of the stent 105-m.In such cases, the hinged valve may be coupled to the polymer jacket1410.

FIG. 15 illustrates a stent delivery system 1500 with a stent 105-n witha self-sealing membrane in accordance with aspects of the presentdisclosure. Once the guidewire lumen 120 and the guidewire are withdrawnthrough the hole in the wall of the stent 105-n, the coverage member1505 may at least partially cover the hole in the wall of the stent105-n. For example, the coverage member 1505 may be an example of aself-sealing membrane material disposed on an outer surface of the wallof the stent 105-n. The self-sealing membrane material may be configuredto seal the hole in the wall of the stent 105-n when the guidewire lumen120 is withdrawn through the hole in the wall of the stent 105-n. Forexample, the self-sealing membrane material may include a pin hole thatcloses to a diameter to prevent bile leakage.

FIG. 16 shows a flowchart illustrating a method 1600 for stenting a bodylumen 180 in accordance with various aspects of the present disclosure.The steps of method 1600 may be performed with any of the systems orcomponents described with reference to FIGS. 1-11 and may be an exampleof aspects of the particular procedure described with reference to FIGS.10-11. At block 1605, the method 1600 may include delivering a stent 105through an access site 185 of a body lumen 180. As described withreference to FIGS. 1-9, the stent 105 may comprise a stent body 135 anda deployable member 130. At block 1610, the method 1600 may furtherinclude deploying the deployable member 130 from the stent body 135 tocover the access site 185.

FIG. 17 shows a flowchart illustrating a method 1700 for stenting a bodylumen 180 in accordance with various aspects of the present disclosure.The steps of method 1700 may be performed with any of the systems orcomponents described with reference to FIGS. 1-11 and may be an exampleof aspects of the particular procedure described with reference to FIGS.10-11. At block 1705, the method 1700 may include delivering a stent 105through an access site 185 of a body lumen 180. As described withreference to FIGS. 1-9, the stent 105 may comprise a stent body 135 anda deployable member 130. At block 1710, the method 1300 may furtherinclude releasing the deployable member 130 from a constrainedconfiguration to deploy the deployable member 130 from the stent body135 to cover the access site 185.

FIG. 18 shows a flowchart illustrating a method 1800 for stenting a bodylumen 180 in accordance with various aspects of the present disclosure.The steps of method 1400 may be performed with any of the systems orcomponents described with reference to FIGS. 1-11 and may be an exampleof aspects of the particular procedure described with reference to FIGS.10-11. At block 1805, the method 1800 may include delivering a stent 105through an access site 185 of a body lumen 180. As described withreference to FIGS. 1-9, the stent 105 may comprise a stent body 135 anda deployable member 130. At block 1810, the method 1800 may furtherinclude pulling on the deployable member 130 to deploy the deployablemember 130 from the stent body 135 to cover the access site 185.

It should be noted that these methods describe possible implementation,and that the operations and the steps may be rearranged or otherwisemodified such that other implementations are possible. In some examples,aspects from two or more of the methods may be combined. For example,aspects of each of the methods may include steps or aspects of the othermethods, or other steps or techniques described herein.

The description herein is provided to enable a person skilled in the artto make or use the disclosure. Various modifications to the disclosurewill be readily apparent to those skilled in the art, and the genericprinciples defined herein may be applied to other variations withoutdeparting from the scope of the disclosure. Thus, the disclosure is notto be limited to the examples and designs described herein but is to beaccorded the broadest scope consistent with the principles and novelfeatures disclosed herein.

While several embodiments of the present disclosure have been describedand illustrated herein, those of ordinary skill in the art will readilyenvision a variety of other means or structures for performing thefunctions or obtaining the results or one or more of the advantagesdescribed herein, and each of such variations or modifications is deemedto be within the scope of the present disclosure. More generally, thoseskilled in the art will readily appreciate that all parameters,dimensions, materials, and configurations described herein are meant tobe exemplary and that the actual parameters, dimensions, materials, orconfigurations will depend upon the specific application or applicationsfor which the teachings of the present disclosure is/are used.

Those skilled in the art will recognize, or be able to ascertain usingno more than routine experimentation, many equivalents to the specificembodiments of the disclosure described herein. It is, therefore, to beunderstood that the foregoing embodiments are presented by way ofexample only and that, within the scope of the appended claims andequivalents thereto, the disclosure may be practiced otherwise than asspecifically described and claimed. The present disclosure is directedto each individual feature, system, article, material, kit, or methoddescribed herein. In addition, any combination of two or more suchfeatures, systems, articles, materials, kits, or methods, if suchfeatures, systems, articles, materials, kits, or methods are notmutually inconsistent, is included within the scope of the presentdisclosure.

All definitions, as defined and used herein, should be understood tocontrol over dictionary definitions, definitions in documentsincorporated by reference, or ordinary meanings of the defined terms.

The indefinite articles “a” and “an,” as used herein in thespecification and in the claims, unless clearly indicated to thecontrary, should be understood to mean “at least one.” Also, as usedherein, including in the claims, “or” as used in a list of items (forexample, a list of items prefaced by a phrase such as “at least one of”or “one or more”) indicates an inclusive list such that, for example, alist of at least one of A, B, or C means A or B or C or AB or AC or BCor ABC (i.e., A and B and C).

Reference throughout this specification to “one embodiment” or “anembodiment” means that a particular feature, structure, orcharacteristic described in connection with the embodiment is includedin at least one embodiment. Thus, appearances of the phrases “in oneembodiment” or “in an embodiment” in various places throughout thisspecification are not necessarily all referring to the same embodiment.Furthermore, the particular features, structures, or characteristics maybe combined in any suitable manner in one or more embodiments.

What is claimed is:
 1. A method of stenting a body lumen, the methodcomprising: delivering a stent through an access site of the body lumen,the stent comprising a stent body and a deployable member; and deployingthe deployable member from the stent body to cover the access site. 2.The method of claim 1, wherein deploying the deployable member comprisesreleasing the deployable member from a constrained configuration.
 3. Themethod of claim 1, wherein deploying the deployable member comprisespulling on the deployable member.
 4. A system for delivering a stentinto a body lumen, the system comprising: a stent; a stent deliverysystem configured to deliver the stent through an access site in a wallof the body lumen; a tubular member configured to retract the stenttoward the access site such that a proximal portion of the stent atleast partially covers the access site, wherein the stent is disposedonto the tubular member such that the tubular member extends inside thestent along a distal portion of the stent, extends through a hole in awall of the stent, and extends outside of the stent along the proximalportion of the stent; and a coverage member configured to at leastpartially cover the hole in the wall of the stent upon withdrawing thetubular member through the hole in the wall of the stent.
 5. The systemof claim 4, wherein the coverage member comprises a self-sealingmembrane material disposed on an outer surface of the wall of the stentand configured to seal the hole in the wall of the stent uponwithdrawing the tubular member through the hole in the wall of thestent.
 6. The system of claim 4, wherein the coverage member comprises aflap valve configured to seal the hole in the wall of the stent uponwithdrawing the tubular member through the hole in the wall of thestent.
 7. The system of claim 4, wherein the coverage member comprises ahinged valve configured to hinge such that upon withdrawing the tubularmember through the hole in the wall of the stent, the hinged valvehinges to at least partially cover the hole in the wall of the stent. 8.The system of claim 7, further comprising: a polymer jacket disposed onan outer surface of a central portion of the stent, wherein the coveragemember is coupled with the polymer jacket.